Catheter devices, needle assemblies, kits and methods

ABSTRACT

Examples of catheter devices, removable needle devices and kits are disclosed. Also methods for accessing a hollow organ are disclosed. The catheter devices include a body extending longitudinally from a proximal end to a distal end, wherein the body includes an elongated channel along the longitudinal length of the body extending from the proximal end to the distal end of the body, wherein the channel is configured to receive an elongated needle of a removable needle device, and the body includes one or more cutting edges extending in a proximal direction from a distal end of the body. The body of the catheter device includes one or more recesses adapted to mate with one or more catches of the needle device for coupling the needle device to the catheter device. Methods of using the catheters, removable needle devices and the kits are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/264,953, filed Feb. 1, 2019, which relates to and claims the benefitand priority to International Application No. PCT/EP2017/069323, filedJul. 31, 2017, which relates to and claims the benefit and priority toEuropean Patent Application No. EP16382384.2, filed Aug. 3, 2016.

FIELD

The present disclosure relates to catheter devices configured to provideaccess to hollow organs. The present disclosure further relates to kitsincluding such catheter devices and methods for using catheter devices,in particular for accessing hollow organs. Hollow organs, as used hereinexplicitly include bodily lumens, e.g. cavities and tubular organs.

BACKGROUND

Medical procedures to obtain access through a patient's skin to holloworgans such as e.g. blood vessels are widely used and for many differentkinds of interventions, e.g. endovascular repair, angioplasty, insertionof chest drains etc.

One known technique used in such procedures is the Seldinger techniquewhich can be used e.g. for vascular access, or for placement of pleural,peritoneal, cardiac, and enteral drains and tubes. This procedureusually involves the following steps depicted in FIG. 1: A puncture isperformed with an introducer needle (or “trocar”) 20 placed through thepatient's skin and into the hollow organ 21 of concern (step A). Asoft-tipped guide wire 22 is then passed through the lumen of theintroducer needle 20 and brought into a desired position within thehollow organ 21 (step B). Then, the needle 20 is withdrawn while theguide wire 22 remains in the hollow organ 21 (step C). At this point ofthe procedure, a guide catheter 23 e.g. a blunt cannula or other deviceswhich allows investigation or treatment of the hollow organ may bepassed over the guide wire (step D). Once the guide catheter 23 isplaced in the correct position for investigation or treatment of thehollow organ, the wire is removed (step E).

The guide catheters by necessity are larger than the guide wire overwhich they are passed and hence cannot pass through the skin via thesmall hole made by the initial needle puncture, thus an enlargement ofthe puncture site may be needed. For this reason, a small skin incisionis made adjacent to the puncture site i.e. the point of entry of theguide wire into the skin. This enlargement of the puncture site may bemade with a sharp instrument e.g. a surgical scalpel. However, thisrequires great dexterity and it is difficult to make a precise incision.Accidents can occur if the incision is made too deep or too long in casethe surgeon does not have a good enough control. This may lead tohemorrhage or perforation of the hollow organ (e.g. vein). In addition,creating and enlarging the puncture site may be time consuming, whichincreases stress for the patient. There is also the risk of cutting theguide wire, which is a very thin wire. And it also happens that a cut ismade which is not exactly at the puncture site. Moreover the proceduresupposes a risk for accidental injury for the practitioner.

WO2016015787 discloses a catheter device configured to provide access toa hollow organ. It includes a body extending longitudinally from aproximal end to a distal end and a flexible insertion tube extendinglongitudinally from a proximal end to a distal end, wherein the bodycomprises: an elongated channel along the longitudinal length of thebody extending from the proximal end of the body to the distal end ofthe body, wherein the channel is configured to receive an elongateneedle. The body further comprises one or more cutting edges extendingrearwardly from a distal end of the body. Furthermore, the flexibleinsertion tube of the catheter device is coupled to the distal end ofthe body and comprises a tubular elongated passage aligned with thetubular elongated channel of the body forming a lumen.

WO2007035889 describes an introducer apparatus with a plurality ofcutting edges along the outer surface of the distal end of an introducerwith a blunt distal end. The introducer may be adapted to extend fromand be withdrawn into the sheath. The cutting edges may resect tissuelocated around the insertion site.

It is an object of the present disclosure to provide improved catheterdevices, needle assemblies, (surgical) kits, and methods that at leastpartially resolve some of the aforementioned problems.

SUMMARY

In a first aspect, a catheter device configured to provide access to ahollow organ is provided. The catheter device comprises a catheter bodyextending longitudinally from a proximal end to a distal end, whereinthe catheter body comprises an elongated channel along the longitudinallength of the catheter body extending from the proximal end to thedistal end of the catheter body, wherein the channel is configured toreceive an elongated needle of a removable needle device. The catheterbody further comprises one or more cutting edges extending in a proximaldirection from a distal end of the body, and one or more recessesadapted to mate with one or more catches of the needle assembly forcoupling the needle device to the catheter device.

Distal herein is to be understood as a side of an instrument furtheraway from a person (e.g. nurse or doctor) using it. Proximal herein isto be understood as the opposite side.

According to this first aspect, a catheter device that is configured toprovide a double function of providing access to a hollow organ and tofacilitate the introduction of larger devices is provided. To this end,the catheter device is provided with one or more cutting edges. Thesecutting edges may enlarge a puncture or a nick previously made in thepatient's skin. Hereby the use of supplementary cutting instruments suchas scalpels may be avoided. With this arrangement, the risk of accidentsthat can occur when manipulating the cutting instrument e.g. cutting offthe guide wire and/or making the nick too deep or too long are alsoavoided. In addition, the risk of making by mistake a second puncturenear the first puncture instead of enlarging the first puncture is alsoavoided since the incision is made larger by simply guiding the catheteralong the guide wire.

In some examples, the needle may be a hollow needle. In some examples,the catheter body may comprise an insertion tube arranged at a distalend of the catheter body, and the lumen of the insertion tube is alignedwith the elongate channel in the catheter body.

The procedure for accessing e.g. a vein through the patient's skin isinherently improved. The catheter with cutting edges as proposed hereinmay be held and used in the same way as traditional trocars or Abbocaths(“hollow needle within a tube”, typically made of Teflon). In a verysimilar manner as in the traditional method, the initial puncture may bemade.

In examples wherein a catheter device including an insertion tube isused, the needle can then be immediately removed. A guide wire may beintroduced into the organ (vein) through the channel in the catheterthat previously surrounded the needle. Once in place, the catheter bodyjust needs to be advanced a bit along the guide wire in order toincrease an incision in a very controlled manner. Since the needle staysin place less time, the risk of an accidental movement by a nurse orother healthcare professional potentially cutting skin or another organis reduced.

In examples wherein the catheter body does not have an insertion tubeand the needle is a hollow needle, the needle may be kept in place whileinserting the guide wire. After introduction of the guide wire, theneedle can be removed. And similarly as before, the catheter body isadvanced over the guide wire to increase the original puncture of theskin.

The catheter may have a variety of shapes. In some examples, thecatheter is substantially flat. The cutting edges may extend rearwardlyfrom a distal end of the catheter device and may be substantiallystraight edges. In other examples, the cutting edges may be curvedoutwardly. Straight edges provide a constant ratio between axialadvancement (of the catheter device) and size of the incision. Edgesthat are curved outwardly may be more smoothly introduced at thebeginning of an incision.

In a further example, a conical cutting edge may be provided. Thediameter of the cone may increase from a distal end of the catheterdevice towards the rear, i.e. towards the proximal end.

In some examples, the one or more cutting edges may comprise consecutivesymmetric marks provided at the cutting edges configured to indicate thelength of the access into the skin of a patient.

In some examples, the body of the catheter device may be made from apolymer, in particular a polymer that can be sterilized. In preferredexamples, the cutting edges and body are integrally formed and made froma suitable polymer. By making the cutting edge from a polymer instead offrom more traditional metallic blades, less danger for personnel usingthe catheter occurs. A catheter could be safely held and nounintentional injury would normally occur.

In some examples, the catheter body may comprise a top surface and abottom surface, and both the top surface and the bottom surface comprisea recess at or near a proximal end of the body.

In another aspect, a needle device having a handle and a needle isprovided. The handle comprises a central portion incorporating a lowerpivot and an upper pivot, and further comprising an upper grip arrangedto pivot around the upper pivot, and a lower grip arranged to pivotaround the lower pivot. The upper grip and lower grip each comprising acatch suitable for mating with a recess in a catheter device, and theneedle comprises cutting portion at a distal end of the needle. Thecentral portion of the handle comprises a handle lumen.

The needle device according to this aspect, allows for easy coupling anduncoupling from the catheter device previously described. Afterpuncturing of the skin and reaching the hollow organ, the assembly canbe easily disassembled and the needle can be removed easily, beforeadvancing the catheter body towards the skin.

In some examples, the upper pivot and the lower pivot may be springbiased. In particular, the upper and lower pivot may be biased towards aposition in which the catches of the grips reach into the recesses ofthe catheter body.

In a further aspect, a kit is provided including a catheter device anyof the examples disclosed herein and a needle device according to any ofthe examples disclosed herein.

In yet a further aspect, a method for accessing a hollow organ isprovided. A catheter device according to any of the examples describedherein coupled with a needle device according to any of the examplesdescribed herein is provided, such that the needle of the needle deviceis positioned in the elongate channel of the catheter body. The methodcomprises making a puncture in a skin of a patient and the hollow organusing the cutting portion of the needle while in the elongate channel ofthe catheter device. At least a distal part of the needle is introducedinto the hollow organ. Then a guide wire is inserted into the elongatechannel of the catheter body lumen such that the guide wire is at leastpartially positioned in the hollow organ. The needle assembly isuncoupled from the catheter device and the needle is removed from thehollow organ. The length of the puncture is increased by inserting thecutting edges of the body of the catheter device into the nick.

In some examples, the needle may be hollow, and the guide wire isinserted while the needle is still in the hollow organ. In otherexamples, the catheter device comprises an insertion tube and the guidewire is inserted after removing the needle from the hollow organ.

The methods may further comprise removing the catheter device over theguide wire after increasing the length of the puncture and passing atreatment catheter over the guide wire. Optionally, the methods maycomprise removing the guide wire.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting examples of the present disclosure will be described in thefollowing, with reference to the appended drawings, in which:

FIG. 1 schematically illustrates a sequence of situations that may occurduring the performance of the prior art Seldinger technique;

FIGS. 2a-2c schematically illustrate a needle device coupled with acatheter device according to an example;

FIGS. 3a-3c schematically illustrate the needle device shown in FIGS. 2a-2 c;

FIGS. 4a-4c schematically illustrate the example of a catheter deviceshown in FIGS. 2a -2 c;

FIGS. 5 schematically illustrates an example of a catheter device whichis similar to the device shown in FIGS. 4a-4c but is provided with aflexible insertion tube; and

FIGS. 6a-6f schematically illustrate a sequence of situations that mayoccur during the performance of a method for accessing a hollow organaccording to an example.

DETAILED DESCRIPTION

FIG. 1 shows a prior art technique for accessing a hollow organ whichhas hereinbefore already been discussed.

FIG. 2a schematically illustrates an isometric view of an assembly 100comprising a catheter device 200, and a needle device 300. The catheterdevice 200 comprises a catheter body 215. The catheter body 215 has atop surface 201 and a bottom surface 202 (as can be seen in more detailin FIG. 2c ). It will be clear that the denomination of top and bottomis arbitrary, as the device can held upside down while retaining theexact same functionality.

The catheter body 215 may extend longitudinally from a proximal end 4 a(closer to the person handling the catheter) to a distal end 4 b (theend further away from the person handling the catheter).

The body 215 may be made of any plastic suitable for any health producte.g. a PVC plastic, a cured epoxy resin, or some other suitable polymer.Such a polymer could be fibre-reinforced in some examples. In someexamples, the distal end 4 b of the body 215 may be relatively sharp,thus the insertion of the body 215 into the patient's skin and a holloworgan of the patient may be facilitated.

FIG. 2b schematically illustrates a top view of the catheter deviceshown in FIG. 2a . The catheter body 215 comprises cutting potions 210which in this example are shown to be curved. The cutting portions 210in this example are formed by the front edges of the catheter body. Insome examples (not illustrated), the cutting portions 210 may besubstantially straight, thus a homogeneous control regarding the speedand the length of the enlargement of the nick previously made may beachieved.

Also in both examples so far, the catheter devices can be substantiallyarrow shaped, but alternative shapes are possible while providing one ormore suitable cutting edges or portions.

The catheter body may further comprise a grip 230, which may have aroughness or textured surface for gripping. The grip 230 is shown inthis example to be located at or near the proximal end of the body 4 a,thus the insertion, removal and manipulation of the body 215 (and thusthe whole catheter) may be improved. The grip 230 may generally beshaped so that it may be easily held between the fingers of theuser/surgeon. The grip may be shaped as a prism with a substantiallyrectangular or square cross-section.

The grip 230 may be made of any suitable rough material e.g. plasticpolymer, thus the manipulation of the catheter by the user/surgeon maybe improved, especially if the grip portion 230 of the catheter is wet,or has saline or body fluids on it. The grip 230 could further have avariety of coatings, including e.g. a hydrophilic coating. With thisarrangement, the catheter device may be easily manipulated and used withgreat accuracy.

As previously commented, the body 215 may comprise one or more cuttingedges 210 extending rearwardly from a distal end of the body 4. In thisparticular example, a first cutting edge 210 and a second cutting edge210 are shown. The cutting edges 210 may be configured to enlarge a nickpreviously made on the patient's skin using e.g. a needle device. A sawshaped portion 250 may also be provided (as will be explained with moredetail in FIGS. 4a-4c ).

The needle device 300 comprises a needle 310 and a handle 320. Theneedle device 300 is shown in more detail in FIGS. 3a -3 c.

The needle device 300 may extend longitudinally from a proximal end 390(closer to the person handling the catheter) to a distal end 391 (theend further away from the person handling the catheter). The needledevice 300 may thus be inserted or withdrawn along a channel defined inthe body of the catheter.

The handle 320 comprises a central portion having a lower pivot 330 andan upper pivot 335 as shown in FIGS. 3b and 3c . These pivots may bee.g. hinges, and in particular they may in some examples be springbiased hinges.

Moreover, a lower grip 326 and an upper grip 325 may be provided. Thelower grip 326 is arranged to rotate around lower pivot 330, and theupper grip 325 is arranged to rotate about the upper pivot 335. Each ofthe distal end 324 of the lower grip 326 and the distal end 322 of theupper grip 325 includes a catch 340 which may be inserted into a recessof the catheter body (illustrated in FIG. 4). The catches 340 may beformed as fingers or protrusions extending from the distal ends of thegrips.

The needle 310 may be coupled at a distal end 329 of the handle 320. Inthis example, the needle 310 is shown to be hollow, including a needlelumen.

The central portion of the handle 320 also comprises an opening 312, asshown in FIG. 3c , connecting with a handle lumen. In this example, thehandle lumen is aligned with and continues in the lumen of the needle. Awire inserted into a proximal end 305 of the handle can thus advanceinto the lumen of the needle.

The removable elongated needle 310 may have diameter in the range e.g.16 to 27 French gauge preferably 18 to 21 French gauge depending on theexpected uses.

FIGS. 4a-4c schematically illustrate an example of the catheter devicein more detail. The catheter body 215 may comprise an elongate channel30 along the longitudinal length of the body extending from the proximalend 4 a of the body to the distal end 4 b of the body 4. A through-holeis thus formed in the body.

In some examples, the channel 30 may have the same diameter at theproximal end 4 a of the body and at the distal end 4 b of the body. Insome other examples, the channel 30 may have a diameter at or near theproximal end 4 a of the body 4 greater than that at or near the distalend 4 b of the body 4 such that the diameter of the channel decreases(optionally constantly) along the longitudinal length of the body 4extending from the proximal end 4 a to the distal end 4 b. This way, thechannel 30 may have the shape of a funnel, thus the fastening (and theoperation) of, for example, a needle device once is inserted into thechannel may be improved. Particularly, the inner channel 30 may bespecifically shaped to provide a seat for a needle (not shown) of acertain kind/size/shape or of a certain brand.

Front edges of the catheter body form cutting edges 210. In thisparticular example, the cutting edges 210 are depicted to besubstantially curved. This configuration may allow a smooth initialintroduction of the cutting edges 210 into the nick previously made onthe patient's skin, thus the accuracy of the enlargement of the nick maybe improved.

One or more of the cutting edges 210 may be provided with a saw-shapedsegment 250. Particularly, this segment may be provided by a so called“crinkle” or saw tooth formation on the cutting edge of the catheter.The saw-shaped segment may comprise a series of five saw toothformations formed in the cutting edge 210, extending along the cuttingedge 210. In a modification, the number of saw tooth formation may beany suitable number depending on the material to be cut. Each formationcomprises side faces. Adjacent formations may be arranged with a gapbetween their side faces. Such a saw shaped portion 250 may be usefulfor cutting a suture wire during an intervention.

In some examples, the cutting edges 210 may be protected with a cover ora protection device suitable to avoid cuts.

The most distal end of the catheter body may be made particularly sharp.

In FIGS. 4a and 4b , a recess 240 is shown in a top surface of thecatheter body. This recess may mate with a catch on the handle of aneedle device. Both the top surface and the bottom surface may comprisesuch a recess.

In this example, the top and/or bottom surface 201, 202 may furthercomprise one or more marks 211 indicating the extent of the incision inthe skin of a patient. These marks 211 may indicate the length of theaccess into the patient's skin (and thus the hollow organ). Each markmay include a sign in a suitable unit of length e.g. millimeters orFrench. For example, the consecutive symmetric marks may beequidistantly spaced apart indicating an incision corresponding to 6 Fr,9 Fr, 12 Fr, 15 Fr etc.

The marks may provide accurate information to the surgeon about theenlargement of the nick, thus the accuracy and the control enlarging thenick may be improved.

The catheter body may further be shaped for ergonomic handling i.e.provided with a grip 230. In particular a proximal portion may have anincreased height as compared to the cutting portions. This makes iteasier for a medical professional to grab and handle the catheter body.The proximal portion may further comprise a textured surface, e.g. aplurality of ribs.

In the example shown, as previously commented, the catheter body 215 mayhave a shape which can be considered arrow-like. The rear edges 235 asshown in FIG. 4b of the arrow may also be used for pushing forward thecatheter body, e.g. to increase an original puncture.

In this example, two small sharp tips 219 are provided at the distal endof the body for facilitating the entry of the body into an initial skinnick. These two small tips are optional so that they may not be there inother examples.

FIG. 5 schematically illustrates the catheter device shown in FIGS.4a-4c provided with a flexible insertion tube.

In this particular example, the catheter body 215 further includes aflexible insertion tube 8. The insertion tube may be made of polymerssuch as Teflon® or Polytetrafluoroethylene (PTFE) which is a syntheticfluoropolymer of tetrafluoroethylene. The flexible insertion tube may becoupled to the distal end 4 b of the catheter body (or couldalternatively be integrally formed with it).

The flexibility of the insertion tube 8 may help with a betterintroduction of the tube into the hollow organ. Furthermore, it canreduce the chances of the hollow organ being punctured or otherwisedamaged e.g. by a sudden or accidental movement. The needle used forinitial puncturing can immediately be removed, whereas a guide wire canstill be introduced into the lumen of the organ through the proximalside of body and the tube.

The flexible insertion tube 8 may comprise a tubular elongate passage 32that is aligned with the elongated channel 30 of the body 215 to definea lumen along the flexible insertion tube 8 and the catheter body.

Other aspects of the catheter device (materials, sizes, dimensions,variations etc.) could be the same as in the various embodimentsillustrated before.

FIGS. 6a-6f schematically illustrate an example of a method of providingaccess to a hollow organ, which in this case is depicted to be a vein400. An assembly 100 comprising a needle device and catheter device isprovided. FIG. 6a illustrates an initial situation. The cutting end ofthe elongated needle 310 makes a puncture 410 in the skin 450 of apatient.

Once the removable needle reaches the vein, blood may drip out at aproximal end of the catheter, thus indicating to the user/surgeon thatthe needle has been properly placed into the vein.

In this example, the needle is a hollow needle, and in a next stepillustrated in FIG. 6b , a guide wire 500 configured to be slidablyinserted and removed through a passage may be provided.

In FIG. 6c , the guide wire 500 is introduced into a proximal portion305 of the handle of the needle device. The guide wire 500 can beadvanced through the hollow needle and into the vein 400. The guide wire500 may have a suitable diameter in order to be inserted into the lumenin the direction pointed by the arrow. The guide wire can further have avery low coefficient of friction, thus the insertion and removal may beimproved. The guide wire may be made e.g. of stainless steel or nitinol,but other materials are of course possible. In some examples, the guidewire may have a handle located at or near a proximal end to facilitatecontrol over the guide wire.

In FIG. 6d , the needle device 300 may be uncoupled from the catheterdevice 200. This may be done by a medical professional pushing the upperand lower grips towards each other. The catches of each of the grips maythus be released from recesses in the catheter body. The needle devicecan then be removed. The needle thus slides rearwardly along the centralpassage in the catheter body. The guide wire 500 stays in place.

In FIG. 6e , the catheter body 215 may advance over the guide wire 500and may be pressed by the user/surgeon towards the skin of a patient. Atthe same time, the skin of the patient may be tightened. The cuttingedges of the catheter body may thus be introduced to increase theincision of the original puncture or nick 410 made on the skin.

In FIG. 6f , the catheter device has already been introduced into thehollow organ (and thus the patient's skin) and the original puncture 410of the needle has been enlarged. The catheter device 200 may thus bewithdrawn. The guide wire 500 still remains located in the vein. Thisway, the guide wire may be used for the insertion of a treatmentcatheter (not shown).

A treatment catheter may comprise a conical tapered distal portion thatis narrower compared to the proximal portion of the catheter. Thetreatment catheter may thus act as a dilator to facilitate advancementof the treatment catheter through the hollow organ. Moreover, thetreatment catheter may provide additional stiffness or reinforcement inthe wall of the hollow organ. Fluoroscopy may be used to confirm theposition of the catheter and to maneuver it to the desired location.

Depending on the intervention, once the treatment catheter has reachedits desired position, the guide wire 500 may be removed.

After completion of an intervention, the treatment catheter may bewithdrawn. In some examples, a sealing device may be used to close theincision made by the procedure.

In alternative methods in which a catheter device with insertion tube isused, the main difference is that the needle device may be retractedbefore insertion of a guide wire. The insertion tube can be used forguiding the guide wire into the vein. After insertion of the guide wire,the method may be substantially the same as hereinbefore described.

For reasons of completeness, various aspects of the present disclosureare set out in the following numbered clauses:

Clause 1. A catheter device configured to provide access to a holloworgan comprising:

-   -   a catheter body extending longitudinally from a proximal end to        a distal end, wherein the body comprises:        -   an elongate channel extending substantially along a            longitudinal direction of the catheter body from the            proximal end to the distal end of the catheter body, wherein            the channel is configured to receive an elongated needle of            a removable needle device,        -   one or more cutting edges extending in a proximal direction            from a distal end of the catheter body, and        -   one or more recesses adapted to mate with one or more            catches of the needle assembly for coupling the needle            assembly to the catheter device.

Clause 2. A catheter device according to clause 1, wherein the catheterbody comprises a top surface and a bottom surface, and wherein both thetop surface and the bottom surface comprise a recess at or near aproximal end of the body.

Clause 3. A catheter device according to any of clauses 1-2, wherein thecutting edges are substantially straight.

Clause 4. A catheter device according to any of clauses 1-2, wherein thecutting edges are substantially curved.

Clause 5. A catheter device according to any of clauses 1-4, furthercomprising marks provided at one or more of the cutting edges configuredto indicate the length of the access into skin of a patient.

Clause 6. A catheter device according to clause 5, wherein the marks areequidistantly spaced apart with respect to each other between 0.5 and1.5 cm.

Clause 7. A catheter device according to any of clauses 1-6, wherein atleast one of the cutting edges comprises a saw-shaped segment.

Clause 8. A catheter device according to any of clauses 1-7, furthercomprising a grip located at or near the proximal end of the catheterbody configured to manipulate the body.

Clause 9. A catheter device according to any of clauses 1-8, wherein thecatheter body is made of a polymer or mixture of polymers.

Clause 10. A catheter device according to any of clauses 1-9, furthercomprising a hollow insertion tube, wherein the insertion tube isattached to the catheter body at a distal end of the body, and wherein alumen of the insertion tube is aligned with the elongated channel of thecatheter body.

Clause 11. A needle device having a handle and a needle, wherein

the handle comprises a central portion incorporating a lower pivot andan upper pivot, and further comprising an upper grip arranged to rotatearound the upper pivot, and a lower grip arranged to rotate around thelower pivot,the upper grip and lower grip comprising a catch to mate with a recessin a catheter device, andwherein the needle comprises a cutting portion at a distal end of theneedle, andwherein the central portion of the handle comprises a handle lumen.

Clause 12. A needle device according to clause 11, wherein the needle isa hollow needle having a needle lumen, and the needle lumen and thehandle lumen form a continuous passage.

Clause 13. A needle device according to clause 11 or 12, wherein thecatch of the upper grip is arranged at or near a distal end of the uppergrip, and the catch of the lower grip is arranged at or near a distalend of the lower grip.

Clause 14. A needle device according to any of clauses 11-13, whereinthe upper pivot and the lower pivot are spring biased.

Clause 15. A needle device according to any of clauses 11-14, whereinthe upper grip and lower grip comprise roughness or a textured portionnear a proximal end of the grips.

Clause 16. A kit including:

-   -   a catheter device according to any of clauses 1-10, and    -   a needle device according to any of clauses 11-15.

Clause 17. A kit according to clause 16, further comprising a treatmentcatheter configured to pass over a guide wire.

Clause 18. A kit according to clause 16 or 17, further comprising aguide wire configured to be advanced and removed through the channel ofthe catheter.

Clause 19. A method for accessing a hollow organ comprising:

-   -   providing a catheter device according to any of clauses 1-10        coupled with a needle device according to any of clauses 11-15,        such that the needle of the needle device is positioned in the        elongate channel of the catheter body,    -   making a puncture in a skin of a patient and the hollow organ        using the cutting portion of the needle while in the elongate        channel of the catheter device;    -   inserting at least a distal part of the needle into the hollow        organ;    -   inserting a guide wire into the elongate channel of the catheter        body lumen such that the guide wire is at least partially        positioned in the hollow organ;    -   uncoupling the needle device from the catheter device;    -   removing the needle from the hollow organ;    -   increasing the length of the puncture by inserting the cutting        edges of the body of the catheter device into the nick.

Clause 20. A method according to clause 19, wherein the needle ishollow, and the guide wire is inserted while the needle is still in thehollow organ.

Clause 21. A method according to clause 19, wherein the catheter devicecomprises an insertion tube and the guide wire is inserted afterremoving the needle from the hollow organ.

Clause 22. A method according to any of clauses 19-21, whereinuncoupling the needle assembly from the catheter device comprisespressing at or near a proximal end of the upper and lower grips andpivoting the upper and lower grips.

Clause 23. A method according to any of clauses 19-22, furthercomprising after increasing the length of the puncture, removing thecatheter device over the guide wire.

Clause 24. A method according to clause 23, further comprising passing atreatment catheter over the guide wire.

Clause 25. A method according to clause 24, further comprising removingthe guide wire.

Clause 26. A method according to any of clauses 19-25, wherein thelength of the puncture is increased until a mark provided at the cuttingedges is reached.

Although only a number of examples have been disclosed herein, otheralternatives, modifications, uses and/or equivalents thereof arepossible. Furthermore, all possible combinations of the describedexamples are also covered. Thus, the scope of the present disclosureshould not be limited by particular examples, but should be determinedonly by a fair reading of the claims that follow.

What is claimed is:
 1. A kit including: a needle device comprising anelongated needle having a proximal end, a sharpened distal end and aninner lumen extending between the proximal end and the sharpened distalend; the needle device further including a handle to which the proximalend of the needle is attached, the handle including an upper griparranged to rotate around an upper pivot and a lower grip arranged torotate around a lower pivot, the upper grip having a proximal endportion located on a proximal side of the upper pivot and a distal endportion located on a distal side of the upper pivot, the lower griphaving a proximal end portion located on a proximal side of the lowerpivot and a distal end portion located on a distal side of the lowerpivot, the upper grip including a first inwardly protruding catch, thelower grip including a second inwardly protruding catch; and a catheterdevice configured to provide access to a hollow organ, the catheterdevice configured to be used with the needle device and comprising acatheter body, the catheter body comprising: a proximal end, a distalend and an outer surface; a grip located at or near the proximal end ofthe catheter body, the grip being configured to allow manipulation ofthe catheter body by a user of the catheter device; an elongate internalchannel extending between the proximal and distal ends of the catheterbody, the elongate internal channel being configured to receive theelongated needle; one or more cutting edges extending in a proximaldirection from a location at or near the distal end of the catheterbody, the one or more cutting edges and the catheter body beingmonolithically formed; and a first recess and a second recess in theouter surface, each of the first and second recesses being located in aproximal end portion of the catheter body, an inside of the first andsecond recesses being configured to respectively receive the first andsecond inwardly protruding catches of the needle device for detachablycoupling the needle device to the top and bottom surfaces of thecatheter body.
 2. The kit according to claim 1, further comprising atreatment catheter configured to pass over a guide wire.
 3. The kitaccording to claim 2, wherein the guide wire is configured to beadvanced and removed through the elongate internal channel of thecatheter device.
 4. The kit according to claim 1, wherein the outersurface of the catheter body includes a top surface and a bottomsurface, and wherein the first recess is located in the top surface andthe second recess is located in the bottom surface.
 5. The kit accordingto claim 4, wherein the grip includes first and second side surfacesfacing in opposite directions and separated by a first distance, atleast a proximal portion of each of the top and bottom surfaces of thecatheter body having a width that extends entirely across the firstdistance.
 6. The kit according to claim 5, wherein the first and secondrecesses are located between the first and second side surfaces of thegrip.
 7. The kit according to claim 1, wherein the catheter devicefurther comprises a flexible insertion tube.
 8. The kit according toclaim 1, wherein the cutting edges of the catheter device are straight.9. The kit according to claim 1, wherein the cutting edges of thecatheter device are curved.
 10. The kit according to claim 1, whereinthe catheter body is made of a polymer or mixture of polymers.
 11. Thekit according to claim 1, wherein the catheter body includes one or moremarks at one or more of the cutting edges, the marks being configured toindicate a length of a cut into skin of a patient.
 12. A method foraccessing a hollow organ comprising: providing a needle device and acatheter device, the needle device comprising an elongated needle havinga proximal end, a sharpened distal end and an inner lumen extendingbetween the proximal end and the sharpened distal end; the needle devicefurther including a handle to which the proximal end of the needle isattached, the handle including an upper grip arranged to rotate aroundan upper pivot and a lower grip arranged to rotate around a lower pivot,the upper grip having a proximal end portion located on a proximal sideof the upper pivot and a distal end portion located on a distal side ofthe upper pivot, the lower grip having a proximal end portion located ona proximal side of the lower pivot and a distal end portion located on adistal side of the lower pivot, the upper grip including a firstinwardly protruding catch, the lower grip including a second inwardlyprotruding catch, the catheter device being configured to provide accessto the hollow organ, the catheter device including a catheter body, thecatheter body having: a proximal end, a distal end, an outer surface; agrip located at or near the proximal end of the catheter body, the gripbeing configured to allow manipulation of the catheter body by a user ofthe catheter device; an elongate internal channel extending between theproximal and distal ends of the catheter body, the elongated needleresiding inside the elongate internal channel; one or more cutting edgesextending in a proximal direction from a location at or near the distalend of the catheter body, the one or more cutting edges and the catheterbody being monolithically formed; a first recess and a second recess inthe outer surface, each of the first and second recesses being locatedin a proximal end portion of the catheter body, an inside of the firstand second recesses being configured to respectively receive the firstand second inwardly protruding catches of the needle device fordetachably coupling the needle device to the top and bottom surfaces ofthe catheter body; making a puncture in skin of a patient and the holloworgan using the sharpened distal end of the elongated needle while inthe elongate internal channel of the catheter device; inserting at leasta distal part of the elongated needle into the hollow organ; inserting aguide wire into the elongate internal channel of the catheter body suchthat the guide wire is at least partially positioned in the holloworgan; detaching the needle device from the catheter device byrespectively removing the first and second inwardly protruding catchesof the needle device from the first and second recesses in the catheterbody; removing the elongated needle from the hollow organ; andsubsequently increasing a length of the puncture by inserting the one ormore cutting edges of the catheter body of the catheter device into thepuncture by guiding the catheter body directly over the guide wire. 13.The method according to claim 12, wherein the guide wire is insertedwhile the needle is in the hollow organ.
 14. The method according toclaim 12, wherein the catheter device comprises an insertion tube andthe guide wire is inserted after removing the elongated needle from thehollow organ.
 15. The method according to claim 14, wherein theinsertion tube remains in the hollow organ at least until the guide wireis inserted into the hollow organ.
 16. The method according to claim 12,further comprising after increasing the length of the puncture, removingthe catheter device from the puncture over the guide wire.
 17. Themethod according to claim 16, further comprising passing a treatmentcatheter over the guide wire.
 18. The method according to claim 12,wherein detaching the needle device from the catheter device comprisespressing at or near a proximal end of the upper and lower grips andpivoting the upper and lower grips.
 19. The method according to claim12, wherein the catheter body includes one or more marks at one or moreof the cutting edges, and wherein the length of the puncture isincreased by inserting the one or more cutting edges of the catheterbody of the catheter device into the puncture until one of the one ormore marks reaches the skin.
 20. The method according to claim 12,wherein the catheter body is made of a polymer or a mixture of polymers.